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NCT06172816 Clinical Trial

A Cohort Study on the Clinical Characteristics and Prognosis of HIV/AIDS Patients Infected With SARS-CoV-2

Covid-19 Clinical Trial

Official title:
The Second Affiliated Hospital of Chongqing Medical University

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06172816
Other study ID # 2023IITxG12
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date December 31, 2024

Study information
Verified date January 2023
Source The Second Affiliated Hospital of Chongqing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

On February 11th, 2020, the International Classification of Viruses named the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as novel coronavirus (COVID-19, Covid-19 for short). At present, COVID-19 has become a global pandemic. However, the persistent replication of HIV in PLWH and the cellular immunodeficiency and persistent inflammation caused by it may have different effects on the susceptibility, severity and course of Covid-19. Several large cohort studies have found evidence of increased risk of hospitalization and death in patients with HIV and Covid-19 co-infection. Meanwhile, a meta-analysis of 22 studies shows that HIV infection is still an important risk factor for acquiring Covid-19 infection, and it is associated with a higher risk of death in COVID-19. In order to further clarify the clinical features and prognosis of HIV co-infection with Covid-19 and explore its immune mechanism, so we will carry out the study.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18-75 years old; Patients diagnosed with HIV in accordance with the Chinese AIDS Diagnosis and Treatment Guidelines. Exclusion Criteria: - Hypertension, diabetes and other metabolic related diseases; Severe circulatory and respiratory diseases; Patients with immune-related diseases and immunosuppressants; Pregnant and lactating women.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• SARS-CoV-2
a virus infection

Locations
Country Name City State
China The second affiliated hospital of Chongqing medical university Chongqing Chongqing

Sponsors (1)
Lead Sponsor Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary clinical features and prognosis the clinical features and prognosis between healthy people and PLWH infected with Omicron 2022.11-2023.1
Primary antibody titer the SARS-CoV-2 specific antibody titers between healthy people and PLWH infected with Omicron 2022.11-2023.1
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